[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54624-54625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2629]


Postmarketing Approaches To Obtain Data on Under-Represented 
Populations in Clinical Trials; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Postmarketing Approaches to Obtain Data on Under-Represented 
Populations in Clinical Trials.'' The purpose of this draft guidance is 
to describe FDA requirements and provide recommendations for obtaining 
safety and effectiveness information on drug and biological products, 
when appropriate, in the postmarketing setting in historically under-
represented patient populations in clinical trials.

DATES: Submit either electronic or written comments on the draft 
guidance by October 10, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2022-D-2629 for ``Postmarketing Approaches to Obtain Data on Under-
Represented Populations in Clinical Trials.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information

[[Page 54625]]

redacted/blacked out, will be available for public viewing and posted 
on https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. If you do not wish your name and contact information 
to be made publicly available, you can provide this information on the 
cover sheet and not in the body of your comments and you must identify 
this information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or Office 
of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or 
Office of the Center Director, Guidance and Policy Development, Center 
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Nicole Gormley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 22, Silver Spring, MD 20993-0002, 240-402-0210; or 
Anne Taylor, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Postmarketing Approaches to Obtain Data on Under-Represented 
Populations in Clinical Trials.'' The purpose of this draft guidance is 
to describe FDA requirements and provide recommendations for obtaining 
safety and effectiveness information on drug and biological products, 
when appropriate, in the postmarketing setting in historically 
underrepresented patient populations in clinical trials. FDA 
regulations require sponsors to present information from premarket 
clinical trials on the safety and effectiveness of drugs in terms of 
gender, age, and racial subgroups. These clinical trials should include 
patient populations that are historically underrepresented in clinical 
research, including but not limited to, populations based on race, 
ethnicity, sex, age, geographic location, gender identity, 
socioeconomic status, disability, pregnancy status, lactation status, 
and co-morbidity. Obtaining information early in development can be 
advantageous in that information may help inform subsequent clinical 
trials and ultimately result in more efficient, informative, and 
successful drug development. However, if despite the sponsor's best 
efforts, these populations are not adequately represented in premarket 
clinical trials or if the data suggests there may be serious safety 
concerns in these populations, it may be appropriate to collect such 
data in the postmarketing setting. Reviews of clinical trial data 
indicate that there is often underrepresentation of patient 
populations, based on race, ethnicity, sex, or age. The draft guidance 
discusses mechanisms by which FDA can require or request information on 
safety and effectiveness be collected in the postmarketing setting; 
design and statistical considerations for subpopulation analyses; and 
postmarketing approaches to obtain information on the benefit-risk 
profile in underrepresented clinical trial populations.
    Underrepresentation in clinical trials remains a significant issue 
despite the Agency's efforts to encourage sponsors and investigators to 
improve representation of historically under-represented patient 
populations. We welcome further dialogue in other settings or 
collaborative efforts to explore methods to enhance representation in 
clinical trials.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 
``Postmarketing Approaches to Obtain Data on Under-Represented 
Populations in Clinical Trials.'' It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 
CFR parts 50 and 56 have been approved under OMB control number 0910-
0130; the collections of information in 21 CFR part 314 have been 
approved under OMB control number 0910-0001; the collections of 
information in 21 CFR part 312 have been approved under OMB control 
number 0910-0014; the collections of information in 21 CFR part 601 
have been approved under OMB control number 0910-0338; and the 
collections of information pertaining to submission of a biologics 
license application (BLA) under section 351(k) of the Public Health 
Service Act have been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17267 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P